Development and Validation of Analytical Procedures for Small Molecules | Module 3: Analytical procedure Development and Prevalidation-Life cycle Management of analytical procedures | Englisch (10239)

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing procedure.

Type of Training: The training is designed as intensive training in four modules of approx. 3 hours each, 11 hours in total. The training is not only designed for less experienced participants but is also very well suited to deepen and consolidate existing knowledge for more experienced participants. The training is provided in English.

Who should participate? Personnel in R&D and QC laboratories for the testing of active substances and pharmaceutical products, medical devices and food supplements. Members RA-CMC teams implementing analytical, validation and stability testing data into the dossier. Quality assurance personnel with focus on analytical laboratory and related responsibilities.

We can offer you favourable graduated prices for group training courses. Please contact us.
You can book these events as a series or individually as part of your webinar contingent.

Module 3

Analytical procedure Development and Prevalidation

• Starting points for the development of analytical procedures
• Optimization of separation | Simulation software
• Development of sufficiently robust test procedures
• Development of stability indicating test methods
• System Suitability testing
• Use of response factors

Life cycle Management of analytical procedures

• Life cycle of analytical procedures (FDA, WHO, ICH Q14)
• New USP chapter <1220> Lifecycle Management of Analytical Procedures and <220> Basic requirements for Lifecycle Management of Analytical Procedures der USP
• Control charts and trending
• Postapproval validation activities and change control
• Adjustment of analytical methods and procedures versus changes

Duration: 150 minutes
Language of presentation: English | Slides: English

...more from your speaker Dr. Markus Veit...

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You can also book all parts of the series at a special price. To do so, select the series in our course calender .

Note on contingent call-off: When booking this webinar described here, one unit will be deducted per participant.

For group enquiries, please contact us directly at info@alphatopics.de.